As part of PEDro’s 25th birthday celebrations in 2024, we added five more trials nominated by PEDro users to PEDro’s Top Trials to form a list of 25 trials. One of these trials was the RESTORE trial, a randomised controlled trial looking at the effect of cognitive functional therapy (CFT) with or without movement sensor biofeedback compared to usual care for chronic, disabling low back pain.
The RESTORE trial was a multicentre 3-armed randomised controlled phase 3 trial that included 492 adults with low back pain (>3 months duration) presenting to primary care physiotherapy clinics in Australia. Participants were randomised into one of three groups: CFT only, CFT + biofeedback, or usual care (e.g. physiotherapy, massage, chiropractic care, medicines, injections, or surgical interventions). The trial found that CFT only and CFT biofeedback were better than usual care for reducing activity limitation.
Learn more about the RESTORE trial in our recent PEDro World-Wide Journal club.
Previous interventions for low back pain have typically produced small and short-term effects. Cognitive functional therapy has shown large effects up to 12 months, but the long-term effects remained unclear.
To assess the long-term effects of the RESTORE trial, participants were invited to participate in a three-year follow-up. 359 (73%) of the 492 participants agreed to participate in the follow-up. 312 (87%) of the 359 participants successfully completed the 3-year follow-up. The results of this follow-up have recently been published in The Lancet Rheumatology. The follow-up demonstrated that both CFT only and CFT + biofeedback were more effective than usual care in reducing activity limitation and pain intensity at 3 years, showing long-term and sustained effects.
